Blood SugarNCT05526937
The Effect of Sprouting of Wheat on Postprandial Glycemic and Satiety Responses of Wheat Bread Products
A study testing Bread in people with Blood Sugar, run by University of Guelph at 1 site in Canada.
Trial summary
The objective of this study is to investigate the effect of inclusion of 50% sprouted wheat wholemeal in a bread recipe on the postprandial glycemic and satiety responses, as well as on appetite-related sensations and acceptability of the developed products relative to a product made with a similar unsprouted wheat… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sugar
- What is being tested?
- Bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 18 Oct 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Age 18-40 years
- Normal non-fasting plasma glucose (<7.9 mmol/L but not below 3.3 mmol/L)
- BMI ranging from 18.5 to 27.9 kg/m2
- Regular consumer of wheat-based bread products (>1x per week).
Who cannot join
- Smoking or regular use of recreational drugs (marijuana, ecstasy, LSD, magic mushrooms etc.)
- Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
- Restrained eater (>16) as defined by the questionnaire at screening (Appendix E: Three Factor Eating Questionnaire, Stunkard et al.,1985)
- Unusual sleep patterns (Shift-worker, or sleeps 4 hours or less regularly) or irregular breakfast consumption.
- Recent (i.e. >4 kg in previous 3 months) or intended weight loss or gain
- Food allergies or any life-threatening allergy (food or otherwise)
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- Gluten intolerance or sensitivity
- Medications known to affect glucose tolerance (excluding oral contraceptives)
- Presence of disease or drug(s) which influence digestion and absorption of nutrients; including steroids, protease inhibitors or antipsychotics.
- Inability to adhere to Study Protocols
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to investigate the effect of inclusion of 50% sprouted wheat wholemeal in a bread recipe on the postprandial glycemic and satiety responses, as well as on appetite-related sensations and acceptability of the developed products relative to a product made with a similar unsprouted wheat recipe.
Read the detailed description
This study is a randomized crossover trial involving three different bread products. At each study visit, capillary blood glucose will be measured at fasting, and then 15, 30, 45, 60, 90, and 120 minutes following the start of ingestion of the study food. Visual analogue scales will be used to assess appetite and fullness sensations at fasting, and then 30, 60, 90 and 120 minutes.
- Conditions
- Blood Sugar
- Being tested
- Bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreadOther
Bread portions of 50 gram available carbohydrates.
| Study group | Role | What they receive |
|---|---|---|
| Sprouted wholemeal bread | Experimental | Not described Receives: Other: Bread |
| Unsprouted wholemeal bread | Active comparator | Not described Receives: Other: Bread |
| White bread | Placebo comparator | Not described Receives: Other: Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Capillary blood glucose
Measured: 2 hours
Secondary outcomes (1)
Postprandial satiety response
Hunger, Fullness, Desire to Eat and Prospective Food Consumption questions using Visual Analogue Scales (100 mm lines). Answers are measured and scored from 0 (not at all) to 100 (extreme).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start18 Oct 2022
- Primary completion15 Mar 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood SugarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Wright, Ph.D., University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526937
- Sponsor's protocol ID
- 22-06-26
- Status last verified
- Dec 2023
- First submitted
- 31 Aug 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sprouting of Wheat on Postprandial Glycemic and Satiety Responses of Wheat Bread Products
- ClinicalTrials.gov ID
- NCT05526937
- Acronym / sponsor ID
- 22-06-26
- Conditions
- Blood Sugar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the effect of inclusion of 50% sprouted wheat wholemeal in a bread recipe on the postprandial glycemic and satiety responses, as well as on appetite-related sensations and acceptability of the developed products relative to a product made with a similar unsprouted wheat recipe.
Detailed description
This study is a randomized crossover trial involving three different bread products. At each study visit, capillary blood glucose will be measured at fasting, and then 15, 30, 45, 60, 90, and 120 minutes following the start of ingestion of the study food. Visual analogue scales will be used to assess appetite and fullness sensations at fasting, and then 30, 60, 90 and 120 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sprouted wholemeal bread | Experimental | Other: Bread |
| Unsprouted wholemeal bread | Active comparator | Other: Bread |
| White bread | Placebo comparator | Other: Bread |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults
- Age 18-40 years
- Normal non-fasting plasma glucose (<7.9 mmol/L but not below 3.3 mmol/L)
- BMI ranging from 18.5 to 27.9 kg/m2
- Regular consumer of wheat-based bread products (>1x per week).
Key exclusion criteria (10 listed)
- Smoking or regular use of recreational drugs (marijuana, ecstasy, LSD, magic mushrooms etc.)
- Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
- Restrained eater (>16) as defined by the questionnaire at screening (Appendix E: Three Factor Eating Questionnaire, Stunkard et al.,1985)
- Unusual sleep patterns (Shift-worker, or sleeps 4 hours or less regularly) or irregular breakfast consumption.
- Recent (i.e. >4 kg in previous 3 months) or intended weight loss or gain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreadBread portions of 50 gram available carbohydrates. | Other | Sprouted wholemeal bread, Unsprouted wholemeal bread, White bread |
Primary outcome
Postprandial glycemic response
Time frame: 2 hours
Capillary blood glucose
1 secondary outcome
Postprandial satiety response
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread in people with Blood Sugar, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glycemic response (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.